acute bronchodilator effects of ipratropium/levosalbutamol 20/50 mcg fixed dose combination vs salbutamol 100 mcg inhaler plus ipratropium 20 mcg inhalation aerosol free combination in patients with stable copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to compare acute bronchodilator effects of ipratropium/levosalbutamol 20/50 mcg fixed dose combination (2 inhalations) via pmdi and salbutamol 100 mcg inhaler (2 inhalations) plus ipratropium 20 mcg inhalation aerosol (2 inhalations) free combination in patients with stable moderate-severe-very severe copd.


Eligibility criteria:
inclusion criteria: * female and male patients aged ≥40 years diagnosed with symptomathic stable moderate-severe-very severe copd: post-bronchodilator fev1/fvc \<70% predicted and a post-bronchodilator fev1 \<80% predicted at screen visit. group b copd cat: ≥10 or mmrc: ≥ 2 exacerbation: 0-1 (not leading to hospital admission) group c copd cat: \<10 or mmrc: 0-1 exacerbation: ≥2 (not leading to hospital admission) or ≥1 (leading to hospital admission) group d copd cat: ≥10 or mmrc: ≥ 2 exacerbation: ≥2 (not leading to hospital admission) or ≥1 (leading to hospital admission) * current or ex-smokers with a smoking history of at least 10 pack-years * patients who have no exacerbation within the last 4 weeks * female patients who use effective contraception * patients who have a capability to communicate with investigator * patients who accept to comply with the protocol * patients who sign written informed consent form exclusion criteria: * history of hypersensitive to anticholinergics or sabas * history of copd exacerbation or lower respiratory track infection that required treatment with antibiotic, oral or parenteral corticosteroid within the last 4 weeks prior the screening visit or during the run-in/wash-out period or history of respiratory tract infection that required treatment with antibiotic within the last 14 days prior the screening visit. * hospitalization due to copd or pneumonia within the last 3 mounts prior the screening visit * use of oral corticosteroid at unstable dosages (i.e. \<6 weeks on a stable dose of prednisone) * sgot (serum glutamic oxaloacetic transaminase) \>80 iu/l, sgpt (serum glutamic pyruvic transaminase) \>80 iu/l, bilirubin \>2.0 mg/dl or creatinine \>2.0 mg/dl * history of asthma, significant chronic respiratory diseases (i.e., significant bronchiectasis, interstitial lung diseases, etc.) other than copd or presence of disease that may be serious and/or potentially affect results of the study. * initiation of an inhaled steroid or change in dose within \<6 weeks prior the screening visit * use of beta-blocker, monoamine oxidase (mao) inhibitor or tricyclic antidepressant within the last 30 days prior the screening visit * recent (within ≤1 year prior the screening visit) history of heart attack, heart failure, acute ischemic heart disease or presence of serious cardiac arrhythmia requiring drug treatment * regularly use of daytime cpap (continuous positive airway measure) oxygen therapy for longer than 1 hour per day * initiation of pulmonary rehabilitation within the 3 months prior the screening visit * history of lung volume reduction surgery * drug or alcohol abuse * presence of active tuberculosis * history of atopy or allergic rhinitis * history of cancer within the last 5 years * attenuated live virus vaccination within the last 2 weeks prior the screening visit or during the run-in/wash-out period * pregnancy or lactation * presence of known symptomatic prostatic hypertrophy requiring treatment * presence of known narrow-angle glaucoma requiring treatment * currently participating in another clinical trial or treatment with another investigational study drug within the last month or 6-half-lives, whichever is longer.

Keywords: copd, ipratropium, levosalbutamol, levalbuterol, salbutamol, albuterol, mdi